Threaded knotless anchor

ABSTRACT

A suture anchor for deployment in a preformed bone hole to secure soft tissue to bone in a knotless manner. The suture anchor comprises a hollow outer member and an inner member longitudinally movable within the outer member. Suture is directed distally between the wall of the bone hole and the outer anchor member from the soft tissue to be attached to the bone transversely across an eyelet situated at the distal end of the inner member and proximally between the wall of the bone hole and the outer anchor member. A rib/groove suture-locking mechanism is provided by moving the inner member proximally relative to the outer member in order to engage the suture-locking mechanism.

BACKGROUND OF INVENTION

1. Field of the Invention

The invention relates to suture anchors for securing sutures and otherfilamentary material to soft tissue. More particularly, the inventionrelates to suture anchors for securing sutures and similar filamentarymaterial to soft tissue to reattach the soft tissue to bone. Still moreparticularly, the invention relates to suture anchors for knotlesslysecuring suture and filamentary material at a surgical site.

2. Description of the Prior Art

In situations where ligaments or other soft tissue are being secured tobone, a suture anchor is commonly employed. The anchor is inserted intoa generally preformed hole in the bone and a suture or similarfilamentary material extends from the anchor and is attached to the softtissue to be secured to the bone. As used herein, the term “bone hole”is used interchangeably with “bone tunnel” and the term “suture”includes monofilament or multi-filament suture as well as any othermetallic or non-metallic filamentary or wire-like material suitable forperforming the function of a suture including both absorbable andnon-absorbable materials.

Whether such surgical procedures are done open or closed, in mostinstances, the suture must be tied to the soft tissue so that a knotmust be formed. When such procedures are done arthroscopically orendoscopically (i.e., closed), creation of a knot is somewhat difficult.As a result, knotless suture anchors have been recently developed toavoid the knot tying step.

One example of a knotless suture anchor is shown in U.S. Pat. No.6,692,516 (West Jr. et al.), assigned to the assignee hereof andincorporated by reference herein. This patent discloses an expandablemetallic knotless suture anchor, the design of which is difficult toimplement with the use of non-metallic material. As used herein, theterm “expandable” means the diameter of the device increases when it isdeployed/anchored in the bone.

U.S. Published patent application 2005/0055052 (Lombardo et al.)discloses a knotless suture anchor which may be made of bioabsorbablematerial. This application is assigned to the assignee hereof andincorporated by reference herein. While the design disclosed in thisreference is compatible with bioabsorbable material, the design is apress-fit design and is limited in the types of surgical procedures forwhich it is suitable. As used herein the term “press-fit” means theanchor is not turned into a bone tunnel and the diameter of the deviceis substantially the same before and after deployment/anchoring in thebone.

Some knotless suture anchors have been developed and one such example isdisclosed in U.S. Pat. No. 8,663,279 (Burkhart et al.). This deviceconsists of a two part anchor in the form of an inner implant, whichreceives suture attached to soft tissue to be repaired, and an outer,cannulated and threaded fixation device designed to be rotated relativeto the inner implant whereby the outer device progressively advancestoward the inner implant and frictionally engages the suture against thewall of the bone tunnel without the need to tie a knot. One difficultywith this type of system is the primary reliance on the quality of bonein the bone tunnel and the difficulty of gauging the relative positionsof the inner and outer components when the components are engaged,thereby making it difficult to optimize the friction fit.

Therefore, the need exists for a simple to use suture anchor whichsecures suture without needing to tie a knot and which removes theprimary dependency of suture security from bone quality.

It is an object of this invention to produce a non-metallic sutureanchor suitable for knotlessly securing suture to attach a first bodytissue to a second body tissue.

It is another object of this invention to produce a knotless sutureanchor suitable for repairing a soft tissue tear, for example, a tornrotator cuff, and re-attaching it to bone, for example, the humeralhead.

It is still another object of this invention to provide a method ofdetermining the relative positions of the components of a knotlesssuture anchor in order to optimize the force with which the suture isheld by the anchor. It is a further object of this invention to providean apparatus for performing this method.

It is also an object of this invention to provide a method and apparatusfor knotlessly securing a suture to a suture anchor where the quality ofthe fixation of the suture is independent of the quality of the boneinto which the suture anchor is placed.

SUMMARY OF INVENTION

These and other objects of this invention are achieved by the preferredembodiment disclosed herein. This invention is a knotless suture anchorassembly for engaging a bone tunnel and holding suture therein toknotlessly secure the suture to soft tissue. The assembly comprises anelongated generally cylindrical hollow outer member having an axiallumen, an outer surface with projections for engaging the wall of thebone tunnel, a distal end and a proximal end and an elongated, generallycylindrical inner member having an axis, a proximal end and a distalend, the distal end having a transverse passage for receiving suturetherethrough. The transverse passage has a proximal and a distal end andis adapted to receive a plurality of sutures in the eyelet. The innermember is adapted to move coaxially relative to the outer member betweena distal, suture-unlocked position and a proximal, suture-lockedposition. A suture joins the soft tissue to the anchor and is directedalong a tortuous path from the soft tissue to the bone tunnel, distallybetween the outer member and the wall of the bone tunnel, through thetransverse passage, and proximally between the outer member and the wallof the bone tunnel. A locking means is interposed between the inner andouter members and is coaxially movable between a suture-unlockedconfiguration, in which the inner member is moveable relative to theouter member so the suture is slidable along the path, and asuture-locked configuration in which movement of the inner memberrelative to the outer member is prevented and the suture is crimpedbetween the proximally facing, distal end of the eyelet and the distalend of the outer member. The invention further includes means for movingthe inner member proximally (relative to the outer member) from thesuture-unlocked position toward the suture-locked position wherein thesuture is crimped between the inner and outer members, means for movingthe outer member distally from the suture-unlocked position toward thesuture-locked position and means for locking the inner member to theouter member to maintain the inner and outer members in thesuture-locked position.

Another aspect of the invention is a method of knotlessly securing softtissue to suture in a bone tunnel and to a suture anchor comprising thesteps of providing a knotless suture anchor as described above,providing an indicator which is viewable from outside the bone tunneland which indicates the position of selected components of the sutureanchor relative to other selected components of the suture anchor atpredetermined points in the process of securing the suture, and lockingthe components of the suture anchor together.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of the preferred embodiment of the driverand anchor assembly showing the driver handle with the trigger lever inthe first position.

FIG. 2 is an enlarged view of the distal end of FIG. 1.

FIG. 3 is a side view of the inner anchor member with a partialcross-section through the proximal end.

FIG. 4 is a side view of the outer anchor member with a partialcross-section.

FIG. 5 is a side view of the actuator shaft.

FIG. 6 is a side view of the driver shaft.

FIG. 7 is an right end view of FIG. 4 without suction.

FIG. 8 is a perspective view of the handle of FIG. 1 with the triggerlever in the second position.

FIG. 9 is a perspective view of the handle of FIG. 1 with the triggerlever in the third position.

FIG. 10 is an exploded perspective view of the handle of the driver.

FIG. 11 is a perspective view of the transport spindle of the driverhandle.

FIG. 12 is a perspective view of the key retainer of the driver handle.

FIG. 13 is a perspective view of the carrier housing of the driverhandle member, partially in cross-section.

FIG. 14 is a perspective view of the actuator coupler.

FIG. 15 is a left perspective view of the trigger lever.

FIG. 16 is a right perspective view of the trigger lever.

FIG. 17 is a diagrammatic view of the anchor tip, suture and tissue tobe repaired with the anchor tip bottomed out in the bone hole during aportion of the method of using the invention.

FIG. 18 is a diagrammatic view of the anchor tip, suture and tissue tobe repaired with the anchor tip bottomed out in the bone hole and thetissue approximated to bone during a portion of the method of using theinvention.

FIG. 19 is a diagrammatic view of the anchor with the outer threadedbody advanced over the inner member and flush with the bone surfaceduring a portion of the method of using the invention.

FIG. 20 is a diagrammatic view of the final configuration of thedeployed (i.e., suture locked) anchor position during a portion of themethod of using the invention.

FIG. 21 is a side elevation view of internal parts of the right handlehousing with some components omitted for clarity.

FIG. 22 is a cross-section view of the handle showing the flexible armwith post taken along the line 22-22.

FIG. 23 is a side elevation view of the right handle assembly of FIG. 21with some components in place and showing the trigger lever in the firstposition.

FIG. 24 is a view of FIG. 23 with the trigger lever shown in the secondposition.

FIG. 25 is a view of FIG. 23 with the trigger lever in the third andfinal position.

FIG. 26A shows the position of anchor components of the inventionrelative to a bone tunnel immediately prior to placement of the outeranchor member component into the bone tunnel.

FIG. 26B shows the position of the handle component of the inventionwhen the anchor components are in the position of FIG. 26A.

FIG. 26C shows the position of the proximity indicator when the anchorcomponents are in the position of FIG. 26A.

FIG. 27A shows the position of anchor components of the inventionrelative to a bone tunnel after advancement of the outer anchor membercomponent of the suture anchor.

FIG. 27B shows the position of the handle component of the inventionwhen the anchor components are in the position of FIG. 27A.

FIG. 27C shows the position of the proximity indicator when the anchorcomponents are in the position of FIG. 27A.

FIG. 28A shows the position of the handle component of the inventionafter completion of the deployment of the inner anchor member.

FIG. 28B shows the position of the anchor components when the handle hasbeen activated as shown in FIG. 28A.

FIG. 28C shows an exploded view of a portion of FIG. 28B showing thelocking engagement between inner and outer anchor members by use of thedistal-most groove on the inner member.

FIG. 28D shows an exploded view of a portion of FIG. 28B showing theengagement of the inner anchor member with the frangible connection toits actuator shaft.

FIG. 28E shows an exploded view of a portion of FIG. 28B showing thecompression of suture between the proximal end of the outer anchormember and the compressive surface at the distal end of the eyelet ofthe inner anchor member.

FIGS. 29A and B show a potential position of certain components if thesuture anchor is not properly inserted.

FIGS. 30A and B show an alternative arrangement of a potential positionof certain components if the suture anchor is not properly inserted.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIGS. 1 and 2, knotless suture anchor 10, constructed inaccordance with the principles of this invention, comprises an inneranchor member 12 and an outer anchor member 14. As will be understoodbelow, anchor members 12 and 14 are components of anchor 10 which areinitially axially spaced from each other at the distal end of driver 200and are joined to the proximal end of driver 200 by respectiveconnecting shafts. The anchor members are designed to become joined inorder to anchor a suture at the surgical work site between components ofanchor 10 as well as between the wall of a preformed bone tunnel and thefacing surfaces of anchor 10.

Referring now to FIG. 3, inner anchor member 12 comprises a generallycylindrical elongated body 16 having a distal end 18, a distal tip 20, aproximal end 22 and an axial lumen 24 aligned with axis 26. Member 12further comprises a transverse eyelet 28 adjacent its distal end 18. Thedistal-most end of eyelet 28 is adjacent a transverse compressionsurface 19 which, as will be understood, ultimately compresses anysuture in eyelet 28 against the distal end of outer anchor member 14.One or more annular locking grooves 30 are provided at the proximal end22 of inner member 12. Member 12 has an axially aligned actuatorengaging shoulder 32 which enables member 12 to be frangibly attached toa narrowed section 34 at the distal end 36 of actuator shaft 40 (bestseen in FIG. 5). Actuator shaft 40 joins inner anchor member 12 toactuator coupler 244 situated at the proximal end of driver handle 204as best seen in FIGS. 10 and 14.

Referring now to FIGS. 4 and 7, outer anchor member 14 comprises acannulated sleeve 50 with projections which, in the preferredembodiment, comprise a threaded exterior surface 52. Sleeve 50 has anaxially aligned lumen 53 with a distal portion 54 having a cylindricalcross-section, a proximal portion 56 having a non-circular (e.g.,hexagonal) cross-section and a pair of diametrically opposed projections58 on its interior surface (only one of which is seen in FIG. 4). Asseen in FIG. 7, a shoulder 51 is produced at the junction between lumenportions 54 and 56. Projections 58 are adapted to engage one of thegrooves 30. When the projections are engaged with a groove, inner member12 is prevented from moving distally, thereby effectively locking theinner and outer members 12 and 14 together as will be understood below.In the preferred embodiment a plurality of grooves 30 is provided sothat the two components 12 and 14 can be locked at a selected positionrelative to each other depending on the number and size of sutures used.Eyelet 28 is created to be large enough to accept a predetermined numberof sutures. In the preferred embodiment, eyelet 28 can receive one tothree strands of (preferably) braided suture which has a diameter ofapproximately 0.63 mm. Use of sutures of this size allows the proximalend of eyelet 28 to accommodate a selected number of sutures while alsoenabling an acceptable degree of compression of the sutures in theeyelet when anchor 10 is deployed (i.e., when the inner and outer anchormembers are locked together). It will be understood that use of a smallnumber of sutures (e.g., one or two) will require engagement of theproximal-most groove 30 a while use of a greater number of sutures willrequire engagement of the distal-most groove 30 b. In the preferredembodiment two grooves 30, longitudinally spaced along axis 210, havebeen found sufficient to exert an acceptable amount of compressive forceover the range of one to three stands of #2 suture for which anchor 10was designed. The compressive force is applied between compressivesurface 19 at the distal end of eyelet 28 and annular compressivesurface 59 at the distal end of outer anchor member 14.

As shown in FIGS. 5 and 6, inner and outer connecting shafts 40 and 62serve to support inner and outer anchor members at the distal end ofdriver 200 while enabling the anchor members to be manipulated by thehandle at the proximal end of driver 200. Outer anchor member 14 isslidably mounted on the distal end 60 of drive shaft 62 (best seen inFIG. 6). Distal end 60 is provided with a coaxial extension 64 having ahexagonal cross-section which mates with proximal portion 56 of thelumen of outer anchor member 14. Drive shaft 62 has an axial lumen 66which is large enough to slidably receive actuator shaft 40 (best seenin FIG. 5). Thus, both inner and outer members 12 and 14 are situated incoaxial alignment with each other at the distal ends of their respectivecoaxial shafts. The proximal ends of each of the shafts are attached tohandle 204 of driver 200. Drive shaft 62 also has a conical tip 68 atits distal end and a keying feature 70 at its proximal end 72, thefunctions of which will be understood below. The conical tip 68 is usedas a retention mechanism which operates by creating a friction fit withthe distal cylindrical lumen 54 of outer anchor member 14. When outermember 14 is placed on the distal end of drive shaft 62 the hexagonallumen portion 56 will be received on distal end 64 with the proximal endof outer member 14 in abutment with shoulder 65. The dimensions of theanchor and driver components are such that, when this happens, conicaltip 68 will extend slightly into cylindrical lumen 54 in order to createa friction fit. This secures outer member 14 to prevent its unintendeddislodgement from the drive shaft during manipulation, such as duringthe step of inserting the anchor into the bone tunnel.

As mentioned above, inner and outer anchor members 12 and 14 arecomponents of anchor 10 which is designed to be anchored in a bone at asurgical work site, and also designed to be deployed in order to engagea suture without the need to tie a knot. The method of using theinvention to place and deploy anchor 10 at the work site, and theelements necessary to carry out the method are best understood byreference to the features and functions of driver 200 which essentiallycomprises handle 204, drive shaft 62 and actuator shaft 40. Driver 200includes means for positioning suture anchor 10, advancing the threadedsleeve 50 of the anchor into bone and deploying and locking sutureanchor 10, thereby securing the suture between the distal end 59 of thethreaded sleeve 50 of outer member 14 and the compressive surface 19 atthe distal side of eyelet 28 of inner member 12 as well as between theanchor and the wall of the bone tunnel (best seen in FIG. 20).

Driver Handle Structure

As best seen in FIGS. 1, 10 and 13, handle 204 comprises a main body 206and carrier housing 208 which is rotatable relative to main body 206about axis 210. Carrier housing 208 has a body 212 with a distal,coaxial aperture 214 which is sized to slidably receive drive shaft 62.Body 212 also has a coaxial bore 216 having threads 218. A proximalflange 220 is adapted to be received proximally of flange parts 222 aand 222 b in order to allow relative rotation between carrier housing208 and main body 206 while preventing translation between them. Mainbody 206 comprises a left handle housing 227 and a right handle housing228. The left and right housings are not exact mirror images of eachother because each has unique internal molded features designed toimplement certain functions of the invention. It will be understood,however, that the description of one of the housings will for the mostpart be sufficient to describe the other.

With respect to the function of driving inner anchor member 12 viaactuator shaft 40, handle 204 receives the proximal end 241 of shaft 40via the axial lumen 66 of drive shaft 62. Proximal end 241 has atransverse bore 242 which receives a pin 243 to couple shaft 40 toactuator coupling 244. Coupling 244, best seen in FIG. 14, comprises ashaft 260 having a transverse indicator disc 262 at its proximal end andan axial bore 264 at its distal end 266 to receive the proximal end ofshaft 40. Shaft 260 has a reduced diameter portion 267 bounded bytransverse distal and proximal force-receiving surfaces 268, 269,respectively. As will be explained below, these surfaces areinstrumental in deploying anchor 10.

With respect to the function of driving outer anchor member 14 via driveshaft 62, handle 204 receives the proximal end 72 of shaft 62 andcouples it in a non-rotating manner via key 280 to spindle 282. Shaft 62has a notch 284 near its proximal end 72. Notch 284 is designed to bealigned with transverse aperture 285 when the proximal end 72 of shaft62 is properly assembled with spindle 282. In this position, key 280will matingly fit with notch 284 to lock shaft 62 to the spindle, bothrotationally and translationally. Spindle 282, best seen in FIG. 11, hasa rectilinear body 286, proximal end 288 and a distal end 290, thelatter being provided with a threaded portion 292. Proximal end 288 isprovided with two diametrically opposed proximity indicators 293 and294, the function of which will be understood below. Spindle 282 alsohas an axial lumen 287 passing entirely through spindle 282 to allowpassage of actuator shaft 40 along axis 210. Spindle body 286 isreceived in recess 288 formed in right housing 228, the recess beingsized to receive the rectilinear body 286 so as to make spindle 282rotatable with handle 204. A mirror image of the recess (not shown) isformed in left housing 227. Each recess has an elongated longitudinallyextending indicator window 290 adapted to receive or allow visibility ofthe outer end of one of the associated proximity indicators 293, 294 soit is visible from the outside of either side of handle 204. Threadedportion 292 is adapted to engage threaded bore 216 of carrier housing208 (best seen in FIG. 13) in order to enable rotation and translationof outer anchor member 14 as handle main body 206 is turned about axis210. The pitch of thread 292 matches the pitch of thread 218 whichmatches the pitch of the outer anchor body thread 50. By having mainbody 206 fixedly coupled to shaft 62, rotating main body 206 will causerotational motion of shaft 62 and preventing rotation of carrier housing208 will cause translation of main body 206. This in turn will causerotational and translational motion of outer anchor member 14, thuscausing it to rotate relative to the bone tunnel and slide alonghexagonal lumen section 56 to rotationally and translationally advancethreaded sleeve 50 longitudinally. (Preventing rotation of carrierhousing 208 enables it to serve as a reference point for the advancementof the anchor.)

As will be understood below, the purpose of proximity indicators 293,294 is to provide, from outside the surgical work site, a visualindication of the location of the distal end 59 of outer anchor member14 relative to the proximal end of eyelet 28 of inner anchor member 12.The proximity indicators 293, 294 slide distally within their associatedproximity window 290 from a starting, proximal-most position (as shownin FIG. 1), to an ending, distal-most position as shown in FIG. 8.Certain elements such as trigger lever 302 and proximity indicator 294are shown in FIG. 8 in solid lines and in phantom lines to indicatetheir positions relative to handle 204 at different points in theprocess of using the invention. That is, proximity indicators 293, 294indicate that when the outer member is placed relative to the bonetunnel as shown in FIGS. 18 and 26A (i.e., when the distal end of theouter anchor member 14 is slightly spaced above the bone tunnel) movingthe indicators a certain distance to align them to the target zoneindicator 295 will align the proximal end of outer member flush with thesurface of the bone in the position shown in FIG. 19, and distal end 59will be aligned with compressive surface 19 which location isrepresented by the proximity indicators 293, 294 being aligned with theproximal side of target zone indicator 295, best seen in FIG. 27B.

It will be understood that other indicating elements may be used otherthan proximity indicators 293, 294 and target indicator 295. Theseindicating elements 293, 294 and 295 serve to communicate to the userthe extent of movement of outer member 14 relative to inner member 12 byuse of a component visible on the surface of handle 204. This movementcan be expressed in a specific distance of travel (16 to 18 mm) of theouter member 14. Other mechanisms could be devised to communicate thisinformation to the user. Such mechanisms could indicate when acomponent, other than spindle 282, fixedly connected to outer member 14has moved a predetermined distance. Another possible indicator mechanismcould be indicia of some kind on either the inner or outer anchormembers 12 or 14 where such indicia could be visible through anendoscope used to view the worksite. Such indicia (e.g., lines, dots,scale, etc.) could identify how much the inner and outer members havemoved relative to each other.

Trigger Mechanism

Once outer anchor member 14 has been advanced far enough into the bonetunnel, i.e., to the position shown in FIG. 19, and a determination hasbeen made that anchor 10 is properly positioned and tensioned, anchor 10may be deployed to the position shown in FIG. 20. With respect to thefunction of deploying anchor 10 by engaging and compressing togetherinner and outer anchor members 12 and 14, handle 204 is provided with atrigger mechanism 300 designed to be selectively engaged with inneranchor member 12, to prevent premature activation of the inner anchormember and to deploy it only at the proper time. Trigger mechanism 300comprises a trigger lever 302 having a unique dual pivot axis structurebest understood by references to FIGS. 21-25. The trigger mechanism isoperable through three positions as represented in FIGS. 1, 8 and 9. Inthe starting, first trigger position, trigger lever 302 lies against thebody of handle 204 as shown in FIGS. 1 and 23. Cocking the trigger bypulling the trigger lever 302 in direction 232 up to a second triggerposition as shown in FIGS. 8 and 24 causes trigger lever 302 to pivotabout first pivot axis 304 and produces tactile and audible feedback dueto pins 50 engaging ramp surfaces 348 and snapping into hollow spaces346, 347 (as described below). Trigger lever 302 will then automaticallyengage a second pivot axis 306. Squeezing trigger lever 302 to move itcounterclockwise about this second pivot axis 306 will actually moveinner anchor member 12 proximally and place lever 302 and handle 204into the third trigger position shown in FIGS. 9 and 25. This alsocauses the user to receive tactile and audible feedback and visualconfirmation of anchor deployment and suture locking. The visualconfirmation is denoted by the disc 262 which protrudes from theproximal end of the handle upon successful anchor deployment.Simultaneously, the frangible connection on actuator shaft 40 atlocation 32 is broken whereby driver 200 is detached from inner anchormember 12 allowing the user to remove the driver, leaving the deployedanchor and sutures in place.

Dual Pivot

The aforementioned trigger lever positions are achievable due to theunique dual pivot axis design of trigger mechanism 300. The triggermechanism has two distinct pivot locations with structures which allowtrigger lever 302 to pivot, first, about a first trigger axis and,second, about a second pivot axis. The pivoting action of trigger lever302 is enabled only when the first and second trigger axes arecoincident with first and second pivot axes, respectively, defined byspecific locations on the main body 206. Trigger lever 302, best seen inFIGS. 15 and 16 is elongated and has a proximal end 310, a distal end312 and a first trigger axis 320 situated between the proximal anddistal ends. The trigger lever 302 has a lever portion 322 at distal end312 and a base portion 326 at proximal end 310. The base portion 326 haselements (explained below) which establish the first trigger axis 320.The right side of trigger lever 302 has two spaced, laterally extendingprojections 327, 328 which are symmetrical about and define axis 320. Atanother point between the proximal and distal ends of trigger lever 302,trigger lever 302 is provided with a pair of opposed, laterallyoutwardly extending hollow pins 340 and 341 coaxially aligned withsecond trigger axis 323. Each pin 340 and 341 is formed of a cylindricalbody 342, 343, respectively, having a cylindrical wall, a rim and ahollow interior space 346, 347 wherein each interior space serves as apivot recess. The proximal side of the rim of each cylindrical wall isprovided with a ramp surface 348 inclined laterally outwardly from itsproximal side to its distal side adjacent the hollow interior spaces346, 347.

As mentioned above, the pivoting action of trigger mechanism 300requires the first and second trigger axes to be coincident with firstand second pivot axes. The first and second pivot axes 304 and 306 aredefined relative to elements on left and right housings 227 and 228. Thefirst and second trigger axes are defined relative to elements ontrigger lever 302. The first pivoting action of trigger lever 302 isoperable when the first pivot axis 304 is coincident with the firsttrigger axis 320 and the second pivoting action is operable when thesecond pivot axis 306 is coincident with the second trigger axis 323.

The transition of trigger lever 302 from being pivotable about one axisto then being pivotable about another axis is demonstrated by FIGS.21-25. The right and left handle housings 228 and 227 each have alaterally inwardly extending pivot pin 350 which is molded into orattached to the end of its associated flexible arm 352. Each arm 352 ishinged at its distal end 354 and is preferably arcuately shaped. Theradius of curvature of each arm 352 is preferably equal to the distancebetween the curved center line (not shown) of arm 352 and first pivotaxis 304. First pivot axis 304 is the midpoint between projections 327and 328. Right handle housing 228 is provided with a curvilinear wall360 provided with retaining gaps 362 and 364 designed to receive theaforementioned projections 327 and 328, respectively. These gaps help toavoid premature translation of actuator shaft 40 by preventing coupling244 from moving so long as the trigger lever is down. The wall 360constrains projections 327, 328 until pivoting of the lever about axis304 is complete, and then the wall enables proximal motion of theprojections (and base portion 326) when lever 302 is pivotedcounterclockwise about axis 306. Trigger lever 302 is mounted betweenleft and right housings 227, 228 and as trigger lever 302 is pivotedclockwise (when viewed as in FIG. 21) about first pivot axis 304, therims of pivot pins 340 and 341 slide along their associated arms 352.(It should be noted that the pins need not contact the arms and theirunbiased position they may be slightly above the arms.) As each pinnears the proximal end of its respective arm 352, the pins willencounter ramp 348 causing its associated arm 352 to flex laterallyoutwardly momentarily to clear pins 340, 341. Further clockwise motionof trigger lever 302 will cause pins 350 to snap back (laterallyinwardly) into the recesses 346, 347, respectively, within each pivotpin whereby a new, second pivot axis 306 will be established for triggerlever 302 as best seen in FIG. 24. The diameters of pins 350 andrecesses 346, 347 are substantially similar in order to enable creationof pivot axis 306.

The base 326 of trigger lever 302 is provided with a pair of parallel,semi-circular projections 360 and 361 adapted to pivot around secondpivot axis 306 along with sound pin 324. As will be understood below,projections 360 and 361 straddle shaft 267 so as to sequentially engagethe transverse actuating surfaces 268 and 269 on coupling 244. The outerperimeter of each of the projections 360, 361 serves as a semi-circularbearing-like surface which actually engages the associated actuatingsurfaces 268, 269 thereby pushing inner anchor member 14 proximally asbest seen in FIG. 25. Sound pin 324 (omitted for clarity in FIGS. 23-25)is situated on the left side of trigger lever 302 so as to pivot aroundsecond pivot axis 306 and slide (again, there could be a slight gap)proximally along its associated flexible arm 370. Arm 370 has alaterally inwardly extending pin (not shown) at its proximal end. Thepin on arm 370 is engaged by a ramp surface 372 on the proximal side ofsound pin 324. As trigger lever 302 nears the end of itscounterclockwise motion about pivot axis 306 the pin on arm 370 willride up ramp 372 (similarly to pins 350 riding up ramp 348 on theirrespective flexible arms 352) until it clears the top 374 of the rampand snaps laterally inwardly onto flat surface 376. It will beunderstood that this arrangement provides a tactile and audibleindication of the completion of the deployment of anchor 10 while disc262 at the proximal end of coupling 244 provides a visual indication.

FIGS. 23-25 show the sequence of operation of trigger mechanism 300about the first and second pivot axes 304 and 306 defined by pivotprojections 327, 328 and pins 340, 341 respectively. Initially, triggerlever 302 is situated in a rest position with lever 302 lying adjacentthe body of handle 204 as shown in FIG. 23. In this position, triggerlever 302 is poised to pivot about axis 304. The actual pivoting oftrigger lever 302 occurs by the user lifting lever 302 away from handle204. This action would also cause flexible arm 352 to flex laterallyoutwardly from each housing 227, 228 until it could snap back intoopposing recesses 346, 347 in projections 341, 342, resulting in the“ready” or cocked position shown in FIG. 24. In this position thetrigger lever 302 has a new pivot axis 306 such that pressing lever 302toward handle 204 will cause projections 360, 361 of base 326 tostraddle section 267 of coupling 244 and pivot about axis 306. Thiscauses projections 360, 361 to engage the proximal most transverseactuating surface 269 attached to the proximal end of the coupler 244 atthe end of actuator shaft 40, thus moving indicator disc 262 proximallyto provide a visual indication of anchor deployment.

The operation of driver 200 is explained by reference to the variouspossible positions of trigger lever 302 relative to other components inthe system. Thus, the first trigger lever position will be defined asthe position of the components at the point in time when trigger lever302 lies along the handle as shown in FIG. 23, which corresponds to theproximity indicators 293, 294 being at the proximal-most position asshown in FIG. 1, which corresponds to the outer anchor member 14 priorto its engagement with the suture as shown in FIG. 17. In this firstposition the two projections 327, 328 situated on one side of triggerlever 302 engage walled section 360 in the right housing 228. Receivingrecesses 362 and 364 engage projections 327, 328 and help to hold thetrigger and inner anchor member in place as best seen in FIG. 23. Thesecond trigger lever position is defined as that corresponding to FIGS.8, 19 and 24 which prepare handle 204 to be placed in a condition readyto retract the inner anchor member 12 into engagement with the outeranchor member 14. This latter condition corresponds to position threeseen in FIG. 25.

Method of Driver Operation

The method of using the invention to determine the relative positions ofthe components of the anchor and the driver is best understood byreference to FIGS. 1, 17-20 and 25-29. To start, the user first createsa bone tunnel 406 of known depth, generally 17-19 mm, and passes one endof suture 400 through tissue 404 to be anchored to the site. Both freesuture limbs 400 and 402 are then passed through loading loop 300 whichis used to draw the suture limbs through eyelet 28 at the distal tip ofthe suture anchor. Loop 300 is attached to a handle 302 which isremovably clipped on to actuator shaft 40 via clip 304. After the sutureis threaded through eyelet 28, the loop and clip are removed. The anchorcomponents are then advanced into the preformed bone hole 406 with thedriver until the anchor's distal tip 20 contacts the floor of the hole(as best seen in FIG. 17). The proximity indicator 294 is in theposition shown in FIG. 1. While holding the anchor stationary the sutureis tensioned until the tissue 404 is approximated to the bone and thedesired tissue position is achieved (as best seen in FIG. 18). Tomaintain this position, the free suture limbs are secured using thecleats 213 in the carrier housing 208. At this point the tension in thesuture causes suture limbs 400, 402 to lie transversely across theproximal end of eyelet 28. Since the position of the suture at theproximal end of eyelet 28 is the position ultimately desired in order tooptimize the friction fit holding the suture in place, the followingsteps of this method are intended to secure the suture in this positionand transfer the tension in the suture from the cleats to the sutureanchor. This is done by engaging the outer anchor member with the bonetunnel thereby compressing the suture against the bone tunnel wall. Theouter anchor member is advanced into the bone tunnel until it is flushwith the surface, thereby maximizing the amount of suture compressedbetween the wall and the anchor. To achieve this, the outer anchormember must be advanced a distance D which is, as shown in FIG. 26A, thedistance between the position of the distal end 59 of outer anchormember 14 and the suture at the proximal end of eyelet 28. This is equalto the distance between the initial starting position of proximityindicator 293, 294 and target zone indicator 295.

Proximity indicators 293, 294 facilitate determination of the anchor'sposition in the bone tunnel. Initially the proximity indicators 293, 294will be situated at the proximal end of their respective proximityindicator window 290 as shown in FIGS. 1 and 26C. Next, the threadedouter body 14 of anchor 10 must be advanced over the inner anchor member12 to deploy anchor 10. This is done by holding the carrier housing 208stationary while rotating the handle 204 clockwise until the outeranchor member 14 is flush with the bone surface (best seen in FIGS. 19and 27A). This position will be indicated when the proximity indicatorsare aligned with the target zone indicator 295, as shown in FIG. 27B, atwhich point the user will know that the outer member 14 is at theposition shown in FIG. 27A, flush with the bone surface and aligned withthe suture situated at the proximal end of eyelet 28. At this pointtrigger mechanism 300 can be cocked so that actuator shaft 40 can beretracted proximally to thereby deploy the inner anchor member 12 bymoving it proximally to crimp the suture between the compressive surface19 of the inner anchor member 12 and the distal end 59 of outer anchormember 14 (best seen in FIG. 20). At this point the inner and outermembers are locked together in a suture-locked configuration by theengagement of either groove 30 a or 30 b with projections 58.

FIGS. 29A and B and 30A and B show the consequences of operating outsidethe range of motion of the proximity indicator and deploying inneranchor member either too deep in a bone hole or too shallow,respectively. In FIG. 29A the inner anchor member is inserted to thebottom of a bone hole that is too deep, and the outer anchor member isthen advanced so as to be flush with the surface of the bone. Thiscauses the suture, when properly tensioned, to lie across the proximalend of eyelet 28. However, because the eyelet is too far away from thedistal end 59 of the outer member, when the inner member is deployed bymoving it proximally to compress the suture and lock the inner and outermembers together there will be too much laxity in the suture as shown inFIG. 29B. This results in decreasing the total frictional holding forceprovided by the anchor. That is, the frictional engagement is onlypresent in the areas where the suture is captured between outer member14 and the bone tunnel wall, and not at the distal end of the anchor.

In FIG. 30A the eyelet and distal tip of anchor 10 are not inserted deepenough into the bone. Under this circumstance there is not enough sutureavailable to reach the bottom of the hole after the soft tissue has beenapproximated. Subsequent advancement of outer anchor member 14 cannot bemade flush with the bone surface, thereby decreasing the surfaces overwhich friction is provided, thereby decreasing the frictional forcesholding the suture against the bone tunnel wall. Also, the anchor standsproud, which is undesirable, and further advancement of the anchor bodyis impeded by frictional forces of the suture against the bone.

While outer anchor member 14 is shown with a threaded outer surfacerequiring rotation of the outer member 14 about axis 210 in order toadvance the outer anchor member toward the inner anchor member tothereby lock the component parts together, it is contemplated that anon-rotatable design could also be used to simply advance the outermember toward the inner member without rotation to thereby lock thecomponents together. The thread on the outer surface of a rotatabledevice is sometimes referred to as a projection for being embedded inthe bone wall, and annular ribs or outwardly extending barbs, etc. arealso deemed projections.

It will be understood that grooves 30 could be actual grooves or could,in cross-section, be in the form of a ratchet and pawl structure (bestseen in FIG. 28C) facilitating flexure of projections 59 when movingproximally and then preventing backwards movement in a distal direction.

It will be understood by those skilled in the art that numerousimprovements and modifications may be made to be preferred embodiment ofthe invention disclosed herein without departing from the spirit andscope thereof.

What is claimed is:
 1. A knotless suture anchor assembly for engaging abone tunnel and holding suture therein to knotlessly secure said sutureto soft tissue comprising: an elongated generally cylindrical hollowouter member having an axial lumen, an outer surface with projectionsfor engaging the wall of the bone tunnel, a distal end and a proximalend; an elongated, generally cylindrical inner member having an axis, aproximal end and a distal end, said distal end having a transversepassage for receiving suture therethrough, said transverse passagehaving a proximal and distal end and adapted to receive a plurality ofsutures in said eyelet, said inner member adapted to move coaxiallyrelative to said outer member between a distal, suture-unlocked positionand a proximal, suture-locked position; a suture joining said softtissue to said anchor, said suture directed along a path from softtissue to said bone tunnel, between said outer member and the wall ofsaid bone tunnel, through said transverse passage, and proximallybetween said outer member and the wall of said bone tunnel; a lockingmeans interposed between said inner and outer members, said lockingmeans coaxially movable between a suture-unlocked configuration, inwhich said inner member is moveable relative to said outer member sosaid suture is slidable along said path, and a suture-lockedconfiguration in which movement of said inner member relative to saidouter member is prevented and said suture is crimped between said distalend of said eyelet and said distal end of said outer member; means formoving said inner member proximally from said suture-unlocked positiontoward said suture-locked position wherein said suture is crimpedbetween said inner and outer members; and means for moving said outermember distally from said suture-unlocked position toward saidsuture-locked position; means for locking said inner member to saidouter member to maintain said inner and outer members in saidsuture-locked position.
 2. A knotless suture fixation according to claim1 wherein said locking means is able to be selectively activated to locka selected number of sutures ranging from one to three.
 3. A method ofknotlessly securing soft tissue to suture and a suture anchor comprisingthe steps of: providing a knotless suture anchor according to claim 1;providing an indicator which is viewable from outside the bone tunneland which indicates the position of selected components of the sutureanchor relative to other selected components of the suture anchor atpredetermined points in the process of securing the suture; and lockingsaid components of said suture anchor together.
 4. A method ofknotlessly securing soft tissue to suture and a suture anchor comprisingthe steps of: providing a knotless suture anchor according to claim 1;providing an indicator which is viewable endoscopically from the worksite and which indicates the position of selected components of thesuture anchor relative to other selected components of the suture anchorat predetermined points in the process of securing the suture; andlocking said components of said suture anchor together.
 5. A method ofknotlessly securing a suture to a suture anchor to attach soft tissue tobone comprising the steps of: providing an elongated suture anchor innercomponent having an elongated inner member with a transverse eyelet atits distal end and at least one first locking means at its proximal end,and an elongated hollow outer member having a second locking meansadapted to selectively engage said first locking means; securing saidinner member to an end of a first elongated drive shaft; securing saidouter member to an end of a second elongated drive shaft which has anaxial lumen large enough to enable said first shaft to slide within saidsecond shaft; providing a suture anchor driver having a handle at itsproximal end, an inner suture anchor body at its distal end and an outersuture anchor body proximal to said inner suture anchor body; said innersuture anchor body releasably attached to an actuator shaft connected tosaid handle, said outer suture anchor body releasably connected to adrive shaft connected to said handle; attaching at least one suture limbto said tissue and through an eyelet in said inner suture anchor body;advancing said outer suture anchor body distally over said proximal endof said inner suture anchor body; providing an indicator means to signalwhen said inner suture anchor body is in a first predetermined positionrelative to said outer suture anchor body; actuating said actuatingshaft to move said inner suture anchor body proximally into said outersuture anchor body; providing at least one locking means to lock saidinner and outer suture anchor bodies together into a secondpredetermined position relative to said other when said suture issufficiently crimped between said inner and outer anchor bodies.
 6. Amethod according to claim 5 wherein said locking means comprises atleast one projection on the inner surface of said outer anchor body anda cooperating annular rib on the outer surface of said inner anchor bodyfor engaging said projection.
 7. A method according to claim 5 whereinsaid actuating step comprises advancing said outer body distally for apredetermined distance.
 8. A method according to claim 5 wherein theactuating means comprises: a trigger means movable between a first andsecond position for enabling motion of said actuating shaft in saidfirst position and for preventing motion of said actuating shaft in saidsecond position.
 9. Method of determining the location of a sutureanchor in a bone tunnel comprising the steps of: forming a bone tunnelhaving a predetermined depth; providing a suture anchor having a distalcomponent with an eyelet; providing a proximal component proximally andcoaxially of said distal component; passing at least one end of suturethrough tissue to be secured and approximating the tissue to apredetermined location relative to the bone tunnel; passing the freeends of the suture through said eyelet; placing the distal end of saiddistal component against the bottom of the bone tunnel; providing anindicator for indicating the position of said proximal component of saidsuture anchor; determining from said indicator when advancement of saidproximal component may be stopped and when said distal component can beretracted to frictionally engage suture between said inner and outermembers.
 10. A method for knotlessly securing suture in a bone tunnelcomprising the steps of: providing a suture; providing a bone hole toreceive a suture anchor; securing the suture to the tissue to befixated; preloading a proximal threaded component of an anchor onto adriver, the proximal component of the anchor defining a pitch andcontaining a lumen comprising a proximal drive area and a distalnon-drive area, the proximal drive area configured to receive the distalportion of a cannulated rotatable and translatable drive shaft;preloading a distal component of said anchor onto an actuator shaft, theactuator shaft being coaxially disposed through the cannulation of therotatable and translatable drive shaft, the actuator shaft being locatedin a first axial position; passing the suture through an eyelet of thedistal component of the anchor, the distal component of the anchorattached to the actuator shaft via a frangible connection; inserting thedistal component of the anchor into a hole in bone until it bottoms out;tensioning the suture to bring the tissue into apposition with bone andthen attaching the suture to a proximal portion of the driver handle;inserting the proximal component of the anchor into the bone hole byrotating the driver while holding another portion of the driver steady,the driver translating at a pitch matched with the pitch of the proximalcomponent of the anchor, the driver also containing an indicator;confirming the placement of the proximal component of the anchorrelative to the distal portion of the anchor by viewing an indicator onthe handle; moving a trigger device to about a first position to therebycause said trigger to pivot about a second position; depressing thetrigger device to translate the actuator shaft to a second position tocompress the suture at the distal end of the proximal anchor and lockthe distal anchor to the proximal anchor.
 11. A trigger for actuating amedical device comprising: a trigger body; means for operativelyconnecting said trigger body to the medical device; a housing forholding said trigger body so the trigger body may be selectively pivotedrelative to two different predetermined points on said housing; a firstpivot axis defined by said housing; a second pivot axis defined by saidhousing; a first trigger axis defined by said trigger body; a secondtrigger axis defined by said trigger body; means for enabling saidtrigger body to be pivotable about said first pivot axis when said firstpivot axis is coincident with said first trigger axis; and means forenabling said trigger body to be pivotable about said second pivot axiswhen said second pivot axis is coincident with said second trigger axis.